Medical connector with closeable male luer

ABSTRACT

A luer connector comprising a housing with a hollow bore having first and second ends. The hollow bore also has a male luer tip and a tapering interior surface. The luer connector also comprises a rigid valve member configured to at least partially extend through the housing. The valve member has a first opened end and a second closed end. The valve member also comprises a passageway within the valve member and an outwardly extending flange near the second end adapted to seal the hollow bore at the second end of the housing when placed in contact with a tapering interior surface of the housing. The valve member further comprises at least one opening near the closed end of the valve member extending outward from the passageway through the valve member and at least one strut attached to the valve member. At least a portion of the strut extends substantially parallel to the central axis of the valve member. The luer connector also comprises a retaining member configured to couple the valve member and the housing and a sealing element disposed within the housing. The sealing element is configured to inhibit fluid communication through the hollow bore of the housing between the interior of the male luer tip of the housing and the first end of the housing.

RELATED APPLICATIONS

This application is related to, and claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 60/696,894, filed Jul.6, 2005 and to U.S. Provisional Patent Application No. 60/707,319, filedAug. 11, 2005, each of which is incorporated in its entirety byreference herein.

BACKGROUND OF THE INVENTIONS

1. Field of the Inventions

This invention relates generally to medical connectors through whichfluids flow, and in particular, to medical connectors with male luers.

2. Description of the Related Art

Systems of connectors, valves, and tubing are routinely used inhospitals and other medical settings for facilitating the transfer offluids to and from patients. It is often a challenge to keep suchsystems sterile and to prevent leakage of fluids when the variouscomponents are engaged and disengaged.

In order to maintain a barrier to bacteria, debris, and fluid leakage,female connectors often have been provided with closures, such as septa,flexible seals, or other impediments, at their mating ends. When a maleluer connector is engaged with the female connector, the closure of thefemale connector is temporarily opened, pierced, or moved to allow fluidto flow between the two connectors. Male connectors typically employneedles or luers to open, pierce, or move the closure on the femaleconnectors.

In many systems, only the female connectors are automatically blockedfrom the external environment when disengaged. Male luer connectors aregenerally not provided with automatic closing mechanisms. Male luerconnectors sometimes employ additional components, such as caps, to stopthe flow of fluid and impede the entry of bacteria and debris. Becausesuch closure mechanisms are not automatic (or not used at all), maleluer connectors are sometimes left unsealed, allowing fluid to drip out.This may increase the risk of unsanitary conditions inside and outsideof the fluid transfer system. In addition, in some medical applicationssuch as certain chemotherapy treatments, the fluids in the tubing andconnectors can be harmful if released.

Moreover, in the busy environment of hospitals and other medicalsettings, health care providers must often quickly manipulate multiplemedical implements with one hand, making it difficult to retrieve maleluer caps and rapidly attach them upon disengagement of male connectors.In addition, male luer connectors are often employed at the downstreamend of gravity-fed fluid sources such as IV bags. When the connectorsand tubing are initially connected to such sources, they are generallyempty (i.e., filled with air) and must be primed with fluid before theycan be connected to a patient. During the priming procedure, fluid isallowed to flow from the upstream end of the tubing toward the male luerconnector on the downstream end. As the flow flows through the tubing,the air in the tubing escapes through the male connector on thedownstream end into the environment. Once the fluid itself reaches themale connector, it can also escape and spill out. Because male luerconnectors do not usually close automatically after priming, the maleluer often drips out a small amount of fluid as the male connector israpidly moved into mating engagement with a female connector. For thisreason, the male luer is generally held over a sink or trash can at theend of the priming procedure to contain the dripping fluid.

There is a need for a closable male luer connector that automaticallyopens when engaged with a female connector and automatically closes whendisengaged from such connector to minimize or eliminate dripping duringpriming and other procedures and to improve the barrier of the fluidtransfer system against bacteria and other debris.

SUMMARY OF THE INVENTIONS

Disclosed are various embodiments of medical connectors with closablemale luers. It is contemplated that the features of the variousembodiments disclosed herein are combinable to form additionalembodiments. Such combinations are within the scope of this disclosure.

In an exemplary embodiment, a male luer connector has a main housingwith first and second ends. The second end of the housing comprises amale luer and a shroud surrounding at least a portion of the male luer.The shroud has screw threads disposed on an internal wall thereof. Atubular valve member with a fluid pathway is disposed within thehousing. The valve member has a tip on its second end. In the regionnear the tip, a pair of fluid holes is positioned on opposite sides ofthe valve member. The tip is configured to abut snugly against aninternal wall of the male luer in a region at or near the second end ofthe male luer. The valve member also has a pair of struts directedtowards the second end. The struts extend axially through a portion ofthe housing, and the ends of the struts towards the second end arepositioned within a space between the male luer and the shroud on thesecond end of the housing. A length of medical tubing is connected tothe connector. An end of the tubing is attached to the first end of thevalve member by adhesive, welding, or some other means. A resilient,elastomeric member extends from a mid-section region on the outside ofthe housing to a region at or near the first end of the valve memberwithin the housing.

In a substantially closed state, the resilient member is configured topull the housing and the tubular valve member together along theirrespective axes. In this state, the tip of the valve member is pressedinto close contact with a portion of the internal wall on the second endof the male luer, and fluid flow from the medical tubing through thetubular valve member is impeded. Fluid generally cannot escape throughthe opening on the second end of the male luer because such opening isblocked by the tip of the valve member.

When a force is applied to separate the valve member from the housing,the resilient member is stretched and the tip of the valve member isdisplaced in the direction of the first end from the second end of themale luer. This separating force can be applied manually, for example,by grasping the external wall of the housing with two fingers andgrasping the tubing adhered to the first end of the valve member withtwo other fingers, and then moving the fingers in opposite direction.The separating force can also be applied automatically by a differentmanual action. For example, the action of connecting the male luer to afemale end of another medical implement can automatically separate thevalve member from the housing. As the advancing end of the femaleconnector proceeds up the screw threads on the second end of the housingof the male luer connector, the female connector makes contact with andexerts a force directed towards the first end against the struts of thevalve member. This force moves the valve member towards the first endagainst the biasing force directed towards the second end exerted by theresilient member. In this opened state, fluid is permitted to flowthrough the opposing holes, around the tip of the valve member, and outof the connector through the gap between the tip of the valve member andthe internal wall on the second end of the male luer. In someembodiments, the valve member is automatically advanced in the directionof the first end when the valve member contacts a fluid conduit (e.g., aspike positioned within a female connector) as the male and femaleconnectors are brought together.

When the separating force is removed, for example, by releasing themanual grip on the housing and the tubing, or by detaching the femaleconnector from the second end of the housing, the resilient member onceagain draws the housing and the valve member together. This causes thetip on the second end of the valve member to abut closely against aportion of the internal wall in a region near the second end of the maleluer, and impedes fluid flow out of the valve.

Also disclosed herein are other features and configurations for theforegoing embodiment, as well as additional embodiments for otherconnectors with closable male luers. Such embodiments generally includemeans for permitting or impeding fluid flow through a male luer on aconnector, preferably automatically upon connection with a correspondingfemale connector.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain embodiments of this invention will now be discussed in detailwith reference to the following figures. These figures are provided forillustrative purposes only, and the invention is not limited to thesubject matter illustrated in the figures.

FIG. 1A shows a perspective view of an embodiment of a male luerconnector attached to tubing configured to receive fluid from a hanginggravity-fed IV bag. In this and other figures, the relative size of theconnector and attached tubing is increased in comparison to otherobjects to facilitate viewing certain details.

FIG. 1B shows a perspective view of the connector of FIG. 1A in astretched, substantially opened configuration.

FIG. 1C shows a perspective view of an embodiment of the connector ofFIG. 1A being connected to an exemplary female connector attached totubing inserted into a patient.

FIG. 2 shows a perspective view of an embodiment of a closeable maleluer connector.

FIG. 3 shows a perspective view of a housing portion of the connector ofFIG. 2.

FIG. 4A shows a perspective view of a valve member portion of theconnector of FIG. 2.

FIG. 4B shows a perspective view of another embodiment of a valve memberportion of the connector of FIG. 2.

FIG. 4C shows a cross-sectional view of the embodiment of the valvemember portion of the connector of FIG. 4B.

FIG. 5 shows a perspective view of a resilient member of the connectorof FIG. 2.

FIG. 6 shows a perspective view of a sealing portion of the connector ofFIG. 2. The relative size of the sealing portion is increased incomparison with the components of the connector shown in other figuresto facilitate viewing.

FIG. 7 shows a perspective view of certain components of the connectorof FIG. 2 in a partially assembled configuration. The housing portion ofFIG. 5 is not shown in FIG. 7.

FIG. 8 shows a cross-sectional view of the connector of FIG. 2 adjacenta female portion of another medical implement. At this stage, fluid isimpeded through the connector of FIG. 2.

FIG. 9 shows a cross-sectional view of the connector of FIG. 2 inengagement with the medical implement of FIG. 8. Fluid is flowingthrough the engaged connectors.

FIG. 10 shows a cross-sectional view of the connector of FIG. 2 adjacentanother medical implement with a closeable female luer connector. Atthis stage, fluid is impeded through the connector of FIG. 2 and thefemale luer connector.

FIG. 11 shows a cross-sectional view of the connectors of FIG. 10 afterengagement. Fluid is flowing through the engaged connectors.

FIG. 12 shows a perspective of the connector of FIG. 2 adjacent asyringe with a male luer tip. At this stage, fluid is impeded throughthe connector.

FIG. 13 shows a perspective view of the components of FIG. 12 afterengagement. At this stage, fluid is still impeded through the connector.

FIG. 14 shows a cross-sectional view of the connector and the male luertip of the syringe of FIG. 13.

FIG. 15 shows a perspective view of the a closeable male luer connectorlocated with its first end adjacent a syringe with a male luer tip andwith its second end located adjacent a hypodermic needle with a femaleluer attachment portion.

FIG. 16 shows a perspective view of the components of FIG. 15 inengagement. At this stage, fluid can flow through the connector.

FIG. 17 is a cross-sectional view of the connector, male luer tip of thesyringe, and hypodermic needle of FIG. 16. At this stage, fluid can flowthrough the connector.

FIG. 18A is a perspective view of another embodiment of a closeable maleluer connector.

FIG. 18B is a cross-sectional view of the connector of FIG. 18A.

FIG. 18C is a detail of the cross-sectional view of the connector ofFIG. 18A.

FIG. 19 is a perspective view of the connector of FIG. 18A locatedadjacent a syringe with a male luer tip.

FIG. 20 is a perspective view of the components of FIG. 19 inengagement.

FIG. 21 is a perspective view of another embodiment of a closeable maleluer connector engaged with a syringe with a male luer tip.

FIG. 22A is a cross-sectional view of another embodiment of a closeablemale luer connector.

FIG. 22B is a detail of the cross-sectional view of the connector ofFIG. 22A.

FIG. 23A is a side view of another embodiment of a closeable male luerconnector with a shroud.

FIG. 23B is a cross-sectional view of the connector of FIG. 23A.

FIG. 23C is a perspective view an embodiment of a closeable male luerconnector adjacent a closeable female connector. At this stage, fluidflow is impeded through the female luer connector.

FIG. 23D is a perspective view of the components of FIG. 23C inengagement.

FIG. 24A is a perspective view of another embodiment of a closeable maleluer connector.

FIG. 24B is a cross-sectional view of the connector of FIG. 24A.

FIG. 25A is a side view of another embodiment of a closeable male luerconnector with a shroud.

FIG. 25B is a cross-sectional view of the connector of FIG. 25A.

FIG. 26A is a perspective view of another embodiment of a closeable maleluer with a flexibly connected female luer connector.

FIG. 26B is a perspective view of another embodiment of a closeable maleluer with a flexibly connected female luer connector.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In one aspect of the present inventions, a variety of means are shownfor closing the second end of a male luer connector. In someembodiments, these closing mechanisms function to prevent and/or impedefluid from escaping from or entering into the male luer, while allowingfluid flow when the male luer is manually opened or engaged with acorresponding female luer. As used herein, terms such as “closed” or“sealed” should be understood as obstructions or barriers to fluid flow.These terms should not be understood to require that a particularstructure or configuration achieves a complete fluid closure in allcircumstances.

In FIG. 1A, an embodiment of a closable male luer connector 10 is shownin a closed position. The luer connector 10 is attached to a gravity-fedIV bag 9 filled with fluid hanging from a pole stand 11. At the bottomof the bag 9, a section of tubing 13 is attached. The opposite end ofthe tubing 13 is connected to the first end 12 of the luer connector 10.A closing mechanism on the interior of the second end 14 of the luerconnector 10 prevents the fluid contained within the bag 9 from flowingthrough the tubing 13 and leaking out of the luer connector 10, as longas the luer connector 10 remains in a closed configuration.

In FIG. 1B, the connector 10 is illustrated in an open position. Fluidcan flow out into the first end 12 of the connector 10 and out of thesecond end 14 of the connector 10. A health care provider can move themale luer connector 10 into this configuration by grasping the secondend of the closable male luer 10 with two fingers, grasping the tubing13 with two other fingers, and gently moving the fingers in oppositedirections.

The IV delivery system illustrated in FIGS. 1A and 1B can be easilyreadied for fluid communication with a patient. In most circumstances,the tubing 13 is filled with air when it is initially connected to theIV bag 9. If the other end of the tubing 13 is connected to a closedconnector, as illustrated in FIG. 1A, the air cannot escape and fluidcannot enter the tubing 13 from the IV bag 9. The luer connector 10 istherefore manually moved into the opened position until all of the airhas been purged through the luer 10 and the fluid in the IV bag 9 fillsthe tubing 13 and connector 10. This procedure is known as “priming.” Assoon as the fluid line and connector are properly primed, the healthcare provider can quickly release the opposing forces applied to thesecond end 14 of the luer connector 10 and the tubing 13, and theclosing mechanism of the luer connector 10 can rapidly stop the flow offluid through the luer connector 10.

Referring now to FIG. 1C, a catheter 17 has been inserted into apatient's arm 15. The catheter 17 penetrates the skin of the arm 15 andis preferably fluidly connected with the patient's bloodstream. Thecatheter 17 is also connected to a length of medical tubing 19 attachedto a female medical connector 21. The example of a female medicalconnector 21 illustrated in FIG. 1C is a version of the Clave® connectormanufactured by ICU Medical, Inc., San Clemente, Calif. Variousembodiments of a connector of this type are illustrated and described inU.S. Pat. No. 5,685,866, which is incorporated herein by reference inits entirety. It is contemplated that many of the male luer embodimentsdisclosed herein can be used with other types of female connectors. Thetubing 19, catheter 17, and female connector 21 were previously primedwith fluid using standard procedures. The luer connector 10 is primed asdescribed previously and brought into engagement with the femaleconnector 21. As described in further detail below, when the maleconnector 10 and female connector 21 are engaged, fluid is permitted toflow from the IV bag 9 into the patient. When the male connector 10 andfemale connector 21 are disengaged, fluid is once again prevented fromflowing out of the second end 14 of the male connector 10. In general,fluid is also prevented from flowing out of the opening in the femaleconnector 21.

The embodiment illustrated in FIGS. 1A-1C is described in further detailbelow. Each of the other embodiments disclosed herein can be used in theillustrated fluid system, and in various modifications and alternativesthereof. Further, it is contemplated that the various embodiments ofconnectors in accordance with the inventions can be used in a widevariety of additional medical fluid systems. For example, the disclosedconnectors can also be used to transfer bodily fluids such as blood,urine, or insulin, nourishing fluids, and/or therapeutic fluids such asfluids used in chemotherapy treatments. The disclosed connectors canalso be used to interconnect various other components of fluid transfersystems.

Referring now to FIGS. 2-9, the closeable male luer of FIGS. 1A-1C isillustrated in greater detail. As illustrated in FIG. 2, the assembledluer connector 10 comprises four portions: a housing 23, a valve member16, a resilient member 18, and a sealing ring 20 (not visible in FIG.2). These portions are individually illustrated in FIGS. 3 through 6,and will be discussed in further detail with reference to these figures.The luer connector 10 can be constructed of more or fewer portions, andsuch portions can be combined into different configurations.

FIG. 3 illustrates the housing 23 of the connector 10, apart from theother portions of the luer connector 1O. The housing 23 is generally atube-like structure with an axial passageway 28 that extends from thefirst end 12 of the connector 10 through the upper housing 34, and themiddle portion 32, and the luer tip 22, to the second end 14 of thehousing 23. In some embodiments, the length of the housing 23 from thefirst end 12 to the luer tip 22 is approximately 1⅛ inches. The housing23 is preferably, but not necessarily, less than or equal to about 1½inches from the first end 12 to the second end 14 so that the weight andbulk of the connector are minimized. The housing 23 can have anysuitable length for a particular application. The luer tip 22 connectsto the remainder of the housing 23 at a base 25 that is surrounded by ashroud 24. The end 27 of the luer tip 22 towards the second end of theluer connector 10 extends some distance beyond the edge 29 of theshroud.

The shroud 24 preferably has inner threads 26 on an interior wall thathelp securely attached the connector 10 in a removable fashion toanother medical implement. In other embodiments, the shroud 24 caninclude other structures or materials for providing a releasableconnection, including quick-release mechanisms and other means. Theshroud 24 includes a plurality of depressions 31 on an outer surface toassist the user in firmly grasping and twisting the shroud 24 of thehousing 23 with the fingers. The depressions 31 have upwardly taperingsidewalls 33 that prevent the fingers from sliding off the connector 10.On an end towards the first end of the connector 10 of each depression31, the surface of the housing 23 is approximately co-planar with thesurface of the depression 31, while on an end towards the second end 14of the connector 12 of each depression 31, the surface of the housing 23is offset from, and preferably lies above, the surface of the depression31. This configuration allows the fingers to comfortably slide in adirection towards the second end 14 of the connector 10 along thehousing 23 into a position for gripping or twisting the connector 10.Once the fingers are in the desired position, a tapered wall 33 on anend towards the second end 14 of the connector 10 of the depression 31resists further movement by the fingers in the direction of the secondend 14. A series of depressions 31 extend around substantially theentire outer surface of the shroud so that the user's fingers, whenpositioned on opposite sides of the connector 10, will likely encountera depression 31 regardless of the orientation of the connector 10 duringuse.

In the illustrated embodiment, the tip 22 has a tapered external wall.The diameter of the tip 22 becomes gradually smaller from the base 25towards the second end 27. The tip 22 includes a hole at its second end27. At the base 25 of the luer tip 22, an interior hole 35 (see FIG. 8)leads into a region of the fluid passageway 28 in the middle portion 32of the luer connector 10. The dimensions of the luer tip can be made tocomply with applicable standards and/or regulations, such as the ANSIstandards.

The interior wall of the luer tip 22 preferably includes a shelf 30 thatextends radially inwardly toward the axis of the fluid passageway 28surrounded by the luer tip 22, making the fluid passageway 28 narrowerat its second end 27 than in the region adjacent to the second end 27.In the illustrated embodiment, the surface of the shelf 29 that facesradially inwardly toward the central axis of the connector 10 is taperedin a manner similar to the taper of the outer surface of the tip 22 (seeFIGS. 8 and 9). In this configuration, the inner diameter of the shelf29 narrows in a direction from the side towards the first end to theside of the shelf 29 towards the second end. As described in furtherdetail below, the shelf 29 in the luer tip 22 helps to block and/orimpede fluid flow through the connector 10 when the second end of thevalve member 16 abuts against it.

The middle portion 32 of the housing 23 lies between the shroud 24 andthe upper housing 34. As illustrated, the middle portion 32 has asmaller outer diameter than either the shroud 24 or upper housing 34.The middle portion 32 also has two generally rectangular openings 36disposed on opposite sides of the housing 23 from each other. When theconnector 10 is assembled, the middle portion 32 is generally covered bya portion of the resilient member 18 (see, e.g., FIG. 2). As a result,the middle portion 32 does not generally come into contact with thefingers during use. Thus, in some embodiments, a grippable surface neednot be used for the middle portion 32. The middle portion 32 cantherefore have a smaller diameter and smoother surface than either ofthe other sections of the housing 23.

The upper housing 34 is generally split into two wall sections 45 a, 45b by two gaps 38 (only one shown in FIG. 3). The upper housing 34includes a series of depressions 37 similar in shape and function to thedepressions 31 on the shroud 24. The upper housing 34 may also compriseone or more protrusions 43 that extend into the gaps 38. In theassembled configuration, the protrusions 43 help to retain a portion ofthe resilient member 18 between the gaps 38 in the wall sections 45 a,45 b (see FIG. 2). In some embodiments, the protrusions 43 are taperedfrom a smaller thickness on their ends towards the first end of theconnector to a larger thickness on their ends towards the second end ofthe connector. The tapering of the protrusions 43 helps in the insertionand retention of the portion of the resilient member 18 in a desiredposition and orientation, while allowing for bending and contortion ofthe resilient member 18 during use. The protrusions 43 also help preventthe valve member 16 from advancing too far in the direction of the firstend as the connector 12 is moved into the opened position by contactingthe set of protrusions 44 toward the second end of the valve member 16.The tapering of the protrusions 43 allows the protrusions 44 of thevalve member 16 to be advanced towards the second end during assemblyinto the housing 23 past the protrusions 43 of the housing 23. Thecorners 47 towards the first end of the connector on each of the wallsections are preferably rounded to prevent snagging, scratching, orother damage or irritation to the fingers or resilient member 18 duringuse.

As shown in FIG. 3, the exterior surface of the upper housing 34includes a lower shelf 39 and the exterior surface of the shroud 24includes a shelf 41 configured to help retain a central portion of theresilient member 18 around the housing 23 in the assembled configuration(see FIG. 2). The shelf 39 of the upper housing 34 is preferablysubstantially horizontal to discourage any sliding of the resilientmember 18 in the direction of the first end of the connector. The shelf41 of the shroud 41 is preferably tapered (see FIG. 8) to assist in theproper positioning of the resilient member 18 on the housing 23 duringmanufacturing of the connector 10.

The housing 23 can be constructed from any of a number of differentmaterials. In some embodiments, the housing 23 can be constructed from arelatively rigid material, such as polycarbonate or other polymericmaterial. The housing 23 and/or valve member 16 of this embodiment, orcomponents of other embodiments, can also be constructed of ahydrophobic material, such as Bayer Makrolon, or any other suitablematerial.

Referring now to FIG. 4A, the valve member 16 of the male luer 10 isillustrated apart from the other components of the connector 10. In someembodiments, the valve member 16 comprises a fluid passageway 52 ofvarying diameter extending from the first end 48 of the valve member 16to the second end 56 thereof, surrounded by additional structures. Nearthe first end 48, the valve member 16 and corresponding section of thefluid passageway 52 are relatively wide to accommodate a section ofstandard-diameter medical tubing inserted therein. Near the middle ofthe valve member 16, a tube 40 surrounding a portion of the fluidpassageway 52 is attached to the portion near the first end of the valvemember 16. The tube is adjacent to two approximately parallel struts 42along at least a portion of the tube 40. The tube 40 can have a circularcross-section or other appropriate cross-section. The struts 42 arepreferably relatively thin and approximately planar. A first end of eachstrut 42 connects to the valve member 16 at approximately the middlesection of the valve member 16, and a second end of each strut extendstoward the second end 56 of the valve member 16. The second end 56 ofthe valve member 16 preferably extends further than the ends of thestruts. There is preferably an open space between the inner wall of eachstrut 42 and the outer wall of the tube 40.

From near the middle of the valve member 16 to the first end 48 thereof,the fluid passageway 52 comprises a wider region with protrusions 44along its external surface. Protrusions 44 form two channels 46 (onlyone is shown in FIG. 4A) lengthwise along opposing sides of the body ofthe valve member 16. In some embodiments, the struts 42 are spacedcircumferentially from the channels 46, as illustrated.

Near the first end of the valve member 16 and tube 40, a circumferentialchannel 48 may be formed around the perimeter of the body of the valvemember 16. Raised tabs 49 can be formed along the edge of the channel 48toward the first end of the connector, while the raised middle portionof the valve member 16 can form the edge of the channel 48 toward thesecond end of the connector. In some embodiments, the raised tabs 49 donot extend evenly about the perimeter of the first end of the valvemember 16, but instead have two larger sections that are spaceddiametrically from each other.

The amount of material necessary to construct the valve member 16 can bereduced by indentations made in the outer layers of this portion. Thetube 40 can have a passage 50 disposed therethrough. This passage 50preferably extends from a hole 52 at the first end of the valve member16 to a pair of holes 50 (only one shown in FIG. 4A) positionedsubstantially adjacent to the second end of the valve member 16. In theillustrated embodiment, these holes 52 are generally rectangular inshape. The region of the tube 40 near the second end of the connectorcan also be formed with only one hole or more than two holes, and othershapes for one or more of the holes can also be employed. For example,the holes 52 can be formed with a tear-drop shape (e.g., narrow on oneend and wider on an opposite end), which facilitates an injectionmolding process of manufacture. Further, in some embodiments, the valvemember 16 can be constructed without a fluid path and function as ablocking plunger for fluid flowing around the valve member 16 ratherthan a means for conveying fluid between the first and second ends ofthe connector 10.

The tube 40 of the valve member 16 comprises, at its second end, aflange section 58. The flange section 58 preferably extends further inthe radial direction than the adjacent portion of the tube 40. In someembodiments, the flange section 58 can be formed of the same orsubstantially the same material as the rest of the tube 40. The flangesection 58 preferably tapers from the first end of the valve member 16towards the second end of the tube 40. In some embodiments, the taper isformed at a 5-degree angle, and has a substantially identical taper tothat of the radially inwardly facing surface of the shelf 30 of thehousing 23. Other amounts of taper, or no taper, can also be used.

The valve member 16, like the housing 23 of FIG. 3, may be constructedfrom a number of different materials. Examples of such materials includepolycarbonate or other polymeric materials. The valve member 16 can beapproximately the same length or somewhat shorter than the housing 23.For example, the length of the valve member 16 can be approximately 1inch. In some embodiments, the valve member 16 can be substantiallyshorter than the length of the housing 23. The valve member 16 can beformed from the same rigid materials as the housing 23. In certainapplications, for example, semi-rigid or even more flexible materialsmay be desirable for use in the valve member 16, and more particularlyfor the flange section 58 toward the second end of the tube 40.

The valve member 16 can be manufactured through injection molding. Insome embodiments, at least two gates are used to facilitate distributionof molten plastic throughout the mold. Preferably, one gate can belocated along one of the sides of the valve member 16 between the end ofthe struts 42 towards the first end of the connector and the raised tabs49 and another can preferably be located near the holes 52 in the valvemember 16. The locations of the gates are not fixed, however, and otherlocations on the valve member 16 can be used for gates when injectionmolding the valve member 16. Constructing both the housing 23 and thevalve member 16 of this or other embodiments out of the same materiallessens the chance of deteriorated performance of the connector 10 dueto thermal expansion/contraction or chemical interaction between theconnector 10 and its environment.

Although the valve member 16 of the illustrated embodiment is configuredas shown in FIG. 4A, many other configurations are possible. In someembodiments, the valve member 16 can be relatively smooth on itsexternal surface, and can principally comprise the tube 40 defining thepassage 50. In still other embodiments, different numbers of struts 42can be disposed along the sides of the valve member 16.

As can be seen in the embodiment illustrated in FIG. 4B, the raised tabs150 near the first end of the valve member 16 can also comprise anexternal engaging surface 150, such as a screw thread, for removablyattaching a medical implement (not shown), such as a syringe, with thefirst end of the valve member 16.

In the embodiment illustrated in FIG. 4C, the channel 48 additionallycan be tapered along the internal surface. The taper of the channel 48can result in a decrease in width of the channel with a larger size atthe first end 180 of the valve member 16 and a smaller size towards thesecond end 184 of the valve member. The internal taper of the channel 48can compliment and closely fit with the taper of a male luer. Such aninternal taper can conform to ANSI standards and/or regulations, such asthe standard for medical syringes. In the illustrated embodiment, thetube 40 of the valve member 16 does not have a flange section 58 thatextends radially outwardly beyond the wall of the tube 40, as in theembodiment of FIG. 4A. Instead, the wall of the tube 40 tapers radiallyinwardly in the region of the second end. The second end 27 a of theluer tip 22 a can have a smaller cross-sectional second portion 170which decreases the likelihood of fluid escaping along the internalsurface of the second end 27 a of the luer tip 22 a. Near the second end27 a of the luer tip 22 a, a larger cross-sectional region 160 cantransition to the smaller cross-sectional portion 170 towards the secondend of the connector in many different ways, such as with an abruptstair-step transition as illustrated in FIG. 4C or with a gradualtapering transition, or other transitions. Some sample cross-sectionaldiameters of the opening at the second end 27 a of the luer 22 a includethose of about 2 mm or less, including about 0.5 mm, 0.75 mm, 1.0 mm,1.25 mm, 1.5 mm, and 1.75 mm. The diameters of the opening in the secondend 27 a can also be in the ranges of 0.4 mm-1.8 mm, 0.5 mm-1.5 mm, and0.5-1.0 mm. Other diameters, either inside or outside the listed rangescan also be used. Additionally, the second end of the valve member 16can be sized appropriately to occupy the space in the opening of thesecond end 27 a of the luer 22 a.

Turning now to FIG. 5, the resilient member 18 is discussed in greaterdetail. In the illustrated embodiment, the resilient member 18 is formedfrom two rings 60, 62 separated by two elastic members 64. The rings 60,62 and/or the elastic members 64 can be made of a deformable materialconfigured to exert a restoring force when stretched. Thus, if the rings60, 62 are pulled in opposing directions, the elastic members 64function to restore the rings 60, 62 to their unextended configuration.

The elastic members 64 can be constructed from a number of elasticmaterials. In some embodiments, the elastic members 64 are made from asilicon rubber elastic material. In other embodiments, the elasticmembers 64 can be made from a shape-memory material. In still otherembodiments, the elastic members 64 and/or the resilient member 18 cancomprise springs or other structures capable of exerting a restoringforce.

The rings 60, 62 can also be constructed from a number of materials. Insome embodiments, the rings 60, 62 are constructed from the samedeformable elastic material that comprises the elastic members 64. Thus,the rings 60, 62 can be stretched into a diameter to extend around theappropriate portion of the housing 23 to which each respective ring 60,62 is attached. The resilience of the rings 60, 62 can function toeffectively hold each ring 60, 62 in place on the housing 23. In otherembodiments, the rings 60, 62 can be constructed from rigid orsemi-rigid materials, and can, for example, comprise half-circles thatcan be snapped into and out of position. In some embodiments, theresilient member 18 can be integrated into the valve member 16 orhousing 23.

Turning now to FIG. 6, the sealing portion 20 is described in greaterdetail. In some embodiments, the sealing portion 20 is substantiallycylindrical and has a bore 66 extending therethrough. In someembodiments, the sealing portion 20 further comprises a pair ofgenerally rectangular protrusions 68 extending from the sidewalls of thecylindrical portion at diametrically opposed positions. The protrusions68 can have different shapes and/or positions. The sealing portion 20can also have a generally smaller-diameter middle portion 67 surroundedby two rings 69 at either end with larger diameters.

The sealing portion 20 can be constructed from a number of differentmaterials. In some embodiments, the sealing portion 20 is made from asilicon-based deformable material 70. Silicon-based deformable materialsare among those that form fluid-tight closures with plastics and otherrigid polymeric materials. The sealing portion 20 can be made from thesame material as the resilient member 18.

In FIG. 7, certain components of the male luer 10 of an embodiment areshown. As illustrated, the housing 23 is omitted. The valve member 16,the resilient member 18, and the sealing portion 20 are shown in theirrespective assembled locations.

Certain interconnections between the various portions of the male luer10 will now be discussed in further detail. As shown, the smaller ring62 of the resilient member 18 fits within the circumferential channel 54of the valve member 16. In some embodiments, the smaller ring 62 can bestretched until it has a larger inner diameter than the raised tabs 49at the first end of the valve member 16. Once the small ring 62 has beenadvanced into position about the circular channel 54, it can bereleased, so that it wraps tightly about the circular channel 54, asshown.

The larger ring 60 of the resilient member 18 extends around the middleportion 32 of the housing 23 (as shown in FIG. 2), and can be stretchedand positioned in a manner similar to that described above with respectto the small ring 62. The elastic members 64 of the resilient member 18can then extend between the small ring 62 and the larger ring 60 of theresilient member 18 and preferably extend along and within the channels46 in the valve member 16. Once located within these channels, theelastic members 64 are, in effect, trapped by the protrusions 44 alongthe channel outer walls. As seen in FIG. 2, the elastic members 64 canalso extend along the gaps 38 in the upper housing 34 of the housing 23.The gaps 38 are generally located above the channels 46 in theillustrated embodiment. The resilient member 18 thereby provides anelastic connection between the housing 23 and valve member 16, pullingthe valve member 16 into engagement with the housing 23.

The sealing portion 20, which is partially hidden by the resilientmember 18 in FIG. 7, preferably fits snugly around the tube 40 and liesin between the struts 42 of the valve member 16.

FIG. 8 illustrates a cross-section of the male luer of the presentembodiment adjacent an exemplary female connector 92. In thiscross-sectional view, the interconnections and interactions between thehousing 23, valve member 16 and sealing portion 20 can be seen ingreater detail. The valve member 16 is configured to be positionedwithin the housing 23. As illustrated, the tube 40 of the valve member16 can be inserted into and through the lumen 28. Meanwhile, the struts42 are configured to pass through corresponding slots that extendlengthwise through the middle portion 32 of the housing 23. In anassembled configuration, the struts 42 are adjacent to the tip 22 alongtwo sides, and the tube 40 is at least partially contained within thetip 22. The protrusions 44 are captured within the gaps 38 formed in theupper housing 34 of the housing 23.

A closing mechanism 56 is adapted to close the fluid passage extendingthrough the closable male luer 10 from fluid communication with theexternal environment, preferably whenever the male luer 10 is notengaged with the female connector 92. In the illustrated embodiment, thefluid passageway 52 comprises the lumen 28 as well as the passage 54 ofthe valve member 16. The closing mechanism 56 of the illustratedembodiment comprises both the flange section 58 of the tube 40 and theinternal taper of the raised portion 29 of the lumen 28. As these twosurfaces contact, they can form a closure at or near the second end 20of the male luer 10.

The substantially matched internal tapering surfaces of the raisedportion 58 of the tube 40 and the raised portion 29 of the lumen 28assist in providing closure of the female connector 92. Preferably arelatively fluid-tight closure is formed. The engagement between theraised portions 29 and 58 can also be created in a number of other ways.In some embodiments, the material of the flange section 58 and thematerial of the raised portion 29 of the lumen 28 are configured to fitclosely together, and are made of sufficiently compatible materials, toform a fluid-tight closure. In other embodiments, the flange section 58,and/or additional portions of the valve member 16, can be constructedfrom a deformable material that more closely follows the contours of theinternal surface of the lumen 28, and the lumen 28 need not have ataper. The sealing portion 20 is configured, in some embodiments, toprevent fluid from escaping from within the male luer connector 10. Whenthe valve member 16 engages the housing 23, the sealing portion 20 sitsbetween the middle portion 32 of the housing 23 and the tube 40. Whenfluid flows within the lumen 28 of the housing 23 and along the outersurface of the tube 40, the fluid is prevented from flowing past themiddle portion 32 by the sealing portion 20, and more particularly bythe rings 69 at either end of the sealing portion 20.

The sealing portion 20 is preferably held in position between thehousing 23 and valve member 16 by the protrusions 68 (see FIG. 6)configured to fit within the holes 36 in the middle portion 32 of thehousing 23. The protrusions 68 help to maintain the sealing portion 20in proper alignment.

With reference to the embodiment illustrated in FIG. 8, the structure ofan exemplary female connector 92 will now be discussed in furtherdetail. The female connector 92 can comprise an elongate body 72 havinga fluid passageway 74 therethrough, and the female connector 92 can havea tip 76 near its distal end. In some embodiments, the tip 76 of thefemale connector 92 has a radially extending surface 78 disposed on itsexternal surface. The female connector 92 can have a fluid conduitpositioned within the female connector 92. The fluid conduit is notincluded or required in all female connectors compatible with theconnectors 10 disclosed herein. Along a proximal inner surface 80 of thefemale connector 92, the fluid passageway 74 is preferably tapered suchthat the diameter of the fluid passageway 74 decreases in the distaldirection.

As shown in FIG. 8, the housing 23, the valve member 16, the resilientmember 18, and the sealing portion 20 are in an assembled configuration,in which the closing mechanism 56 forms a closing engagement between theflange section 58 and the interior of the lumen 28. In addition, thesealing portion 20 is in closing engagement between the valve member 16and the housing 23. Fluid from the passage 50 can flow through thewindows 54 of the tube 40 of the valve member 16. In this position, thewindows 54 communicate with the interior of the tip 22, but not yet withthe external environment. The lumen 28 is closed at its second end bythe closing mechanism 56 and at its first end by the sealing portion 20.

As shown in FIG. 8, the struts 42 of the valve member 16 extend throughslots in the housing 23 such that their ends extend to positions nearthe end of the shroud 24 toward the second end of the connector. Thesestruts 42 are configured to engage the proximal ends 84 of the femaleconnector 92 as the female connector 92 advances into engagement withthe closable male luer 10.

In FIG. 8, the male and female luers are shown in an unengagedconfiguration. To engage the male luer 10 and female connector 92, theradially extending surface 78 of the female connector 92 are screwedinto the inner threads 26 of the male luer 10.

As shown in FIG. 9, the two luers can be threadedly engaged towards oneanother until the taper of the inner surface 80 of the female connector92 lies adjacent the correspondingly tapered external surface of the tip22. In other embodiments, the two luers can be threadedly engaged untilthe second end of the tip 22 forms a closure with a correspondingsurface (not shown) of the female connector 92.

As the male luer connector 10 and female connector 92 move towards eachother into threaded engagement, the proximal end 84 of the tip of thefemale connector 92 contacts the struts 42 of the valve member 16. Asthe male luer connector 10 and female connector 92 move further intothreaded engagement, the struts 42, and thereby the valve member 16, aremoved in the direction of the first end of the male connector by thefemale connector 92, displacing the valve member 16 relative to thehousing 23. Thus, the flange section 58 moves from the second end of thetip 22 of the housing 23 towards the first end of the male connector. Asthese two tapered surfaces separate, a space forms between the valvemember 16 and the housing 23 and fluid is allowed to pass through thehole 30 into the fluid passageway 74 of the female connector 92, or viceversa. When used with some embodiments of the female connector 92, aninternal fluid conduit contacts the second end of the valve member 16before the housing of the female connector 92 contacts the struts 42 toopen the male connector 10. In some embodiments, the closure remainsintact until the inner surface 80 of the tip of the female connector 92has formed a closing engagement with the outer surface of the tip 22 ofthe male luer 10. Thus, the passage 50 of the male luer 10 need not bein fluid communication with the external environment.

As the valve member 16 moves relative to the housing 23, the elasticmembers 64 (not shown in FIG. 9) of the resilient member 18 distend andexert a restoring force. As long as the female connector 92 engages themale luer 10, this restoring force can be resisted by the radiallyextending surface 78 of the female connector 92 contacting the innerthreads 26 of the housing 23. However, when the female connector 92 iswithdrawn from the male luer 10, the resilient member 18 returns thevalve element of the valve member 16 to closing engagement with thelumen 28.

Despite the relative movement between the housing 23 and the valvemember 16, the sealing portion 20 preferably maintains a fluid barrierbetween the outer surface of the tube 40 and the inner surface of thelumen 28. In some embodiments, the position of the sealing portion 20 ismaintained by the protrusions 68. In other embodiments, the sealingportion 20 can be positioned by gluing the outer surface of thedeformable material 70 to the inner surface of the lumen 28 of thehousing 23. Other means of fixing the sealing portion 20 can also beused.

As shown in FIG. 9, in the opened configuration, the fluid passageway 74of the female connector 92 can fluidly communicate with the passage 50of the valve member 16. Fluid can thereby flow from tubing 13 attachedto the male luer 10, into the passage 50 of the valve member 16, throughthe windows 54 into the lumen 28, out from the lumen 28 through the hole30 at the second end of the tip 22 into the fluid passageway 74 of thefemale connector 92, and vice versa. Fluid is prevented from escapingthe male luer 10 through the gap between the housing 23 and valve member16 by the sealing portion 20. A fluid-tight closure can also be formedbetween corresponding tapers of the tip 22 of the housing 23 and theinner surface 80 of the female connector 92.

Turning to FIG. 10, the connector 10 is displayed adjacent to acloseable female luer connector 210. In the sample embodimentillustrated here, the closeable female luer connector 210 comprises anouter housing 213, a void space 212, a fluid passageway 218, a fluidconduit 216 with one or more holes 215, a compressible seal element 214with a proximal surface 217, and a threaded engagement region 211. Thecloseable female connector 210 is positioned with its proximal endadjacent the second end 56 of the male connector 10. The threadedengagement region 211 of the closeable female connector 210 can conformto standard sizing for luer connectors, such as those that meet ANSIstandards. The compressible seal element 214 can be composed ofwater-impermeable, resilient material which can reduce in size when aforce is exerted upon it. The fluid conduit 216 can be composed of arigid material, such as polycarbonate plastic, which is capable ofresisting deformation when a force sufficient to compress the sealelement 214 is exerted upon the closeable female connector 210. Thefluid passageway 218 can place the fluid conduit 216 in fluidcommunication with the second end 219 of the closeable female connector210. At least one hole 215 in the fluid conduit 216 can be sealed by thecompressible seal element 214 to prevent the fluid passageway 218 frombeing in fluid communication with the void space 212 between thecompressible seal element 214 and the inner wall of the housing 213and/or with the exterior of the housing 213. The hole or holes 215 canbe sized appropriately small enough to permit fluid to pass between thefluid passageway 218 and the void space 212 at an appropriate flow rate.One such size for the hole or holes 215 is approximately one millimeterin diameter, although irregular shapes and other sizes can be used.Holes of at least about 1 mm or approximately 1 mm-1 mm, or less thanabout 1 mm can also be used. The connector 10 can be engaged with atubing 13 containing a fluid.

With reference to FIG. 11, the connector 10 can be threadedly engagedwith the closeable female connector 210. The threaded region 211 of thecloseable female connector 210 can engage with the inner threads 26 ofthe male connector 10 to engage the connectors 10, 210, as illustrated.In the illustrated engagement, the luer tip 22 advances into thecloseable female connector 210 by compressing the compressible sealelement 214. As can be seen, the luer tip 22 contacts the compressibleseal element 214 on the proximal surface 217 of the compressible sealelement 214. The force exerted to engage the connectors 10, 210 andengage the threaded regions 26, 211 is sufficient to compress the sealelement 214 to expose the holes 215 in the fluid conduit 216. With theseal element 214 compressed, the fluid passageway 218 is in fluidcommunication with the interior space of the luer tip 22.

As the luer tip 22 advances further into the closeable female connector210, the fluid conduit 216 contacts the end of the valve member 16towards the second end of the male connector. The valve member 16 isdisplaced towards the first end of the male connector by the contact andcontinued advancement of the luer tip 22. The resilient member 18 exertsa closing force in a direction towards the second end of the maleconnector on the valve member 16. As a result, the tip of the valvemember 16 towards the second end of the male connector generallymaintains contact with the fluid conduit 216 throughout the engagement.As the valve member is moved in a direction towards the first end of themale connector, the flange section 58 of the valve member 16 separatesfrom the interior surface of the housing 23 through which the hole 30passes. As a result, the windows 54 are opened to fluid communicationwith the closeable female connector 210. The compressed seal element 214inhibits fluid flow into the interior of the closeable female connector210 beyond the luer tip 22. In this configuration, fluid can flow fromthe tubing 13 at the end of the valve member 16 toward the second end ofthe male connector and into the tube 40 through the windows 54 into theinterior of the lumen 28, out the hole 30 in the luer tip 22, into theinterior of the outer housing 213 of the closeable female connector 210,in the holes 215 of the fluid conduit 216 and into the fluid channel 217in the interior of the fluid conduit 216. Thus, the second end of theconnector 210 is placed in fluid communication with the proximal end 219of the closeable female connector 210. Additionally, the sealing portion20 preferably maintains a fluid barrier between the outer surface of thetube 40 and the inner surface of the lumen 28, confining the flow offluid towards the closeable female connector 210. When the surface ofthe valve member towards the second end of the connector is directlycontacted by a female connector member such as the fluid conduit 216,the struts 42 may not be engaged by the female connector.

The connectors 10, 210 can be threadedly disengaged. During engagement,the force exerted by the resilient member 18 can return the connector 10to its pre-engaged state by directing the valve member 16 to engage theflange section 58 of the end of the valve member 16 toward the secondend of the male connector with the internal surface of the luer tip 22.Likewise, the resilient material of which the compressible seal iscomposed can return to its shape in the closed position and the proximalsurface 217 can seal the proximal tip of the closeable female connector210.

Referring now to FIG. 12, the connector 10 can be engaged with a syringe250. In FIG. 12, the syringe 250 and connector 10 are displayed adjacentto each other. The syringe can comprise a male luer connector 252, aplunger 258, a reservoir 260, and convenient finger anchors 262. Theluer connector 252 can further comprise an internally threaded shroud254 and a syringe luer tip 256. In the illustrated embodiment of theconnector 10, a threaded surface 150 is disposed on the outside surfaceof the first end of the valve member 16.

With reference now to FIG. 13, the connector 10 can be threadedlyengaged with the syringe 250. The shroud 254 can engage with the end 16of the valve member toward the first end of the connector to connect theconnector 10 to the syringe 250. The reservoir 260 of the syringe 250can be placed in fluid communication with the tube 40 interior to thevalve member 16.

Turning to FIG. 14, the engagement illustrated in FIG. 13 is shown in across-sectional view. The syringe 250 is threadedly engaged with theconnector 10 by the engagement between the shroud 254 and the threadedsurface 150 of the valve member 16. The luer tip 252 of the syringe 250is extended into the tube 40 of the valve member 16. The reservoir 260of the syringe, shown here with a fluid in the reservoir 260, is influid communication with the interior of the valve member 16. The fluidcan pass through the tube 40 and towards the luer tip 22 of theconnector 10. In the illustrated embodiment, the fluid cannot exit theconnector 10 out its male luer tip 22 because the flange section 58 isin contact with the interior surface of the lumen 28. Accordingly, thehole 30 in the tip of the housing 23 towards the second end of theconnector is blocked by the valve member 16. In order for the syringe250 and connector 10 to transition from the stage shown in FIG. 12 tothe stage shown in FIG. 14, the valve member 16 may need to betemporarily opened to release air (as described in more detail below).

Referring to FIG. 15, the connector 10 is shown adjacent to and betweena syringe 250 and a hypodermic needle with sheath 270. The syringe 250,like that of FIG. 12, can comprise a male luer connector 252, a plunger258, a reservoir 260, and convenient finger anchors 262. The luerconnector 252 can further comprise an internally threaded shroud 254 anda syringe luer tip 256. The needle with sheath 270 can comprise ahousing 266 with raised tabs 264 on the engagement end and a needle 268.

With reference to FIG. 16, the connector 10 is shown threadedly engagedwith both the syringe 250 and needle with sheath 270. The threadedsurface 150 of the valve member 16 of the connector 10 can engage withthe threaded shroud 154 of the syringe 250. Accordingly, the luer tip256 can protrude into the tube 40 of the valve member 16. Similarly, theraised tabs 264 can engage with the inner threads 26 of the shroud 24 ofthe connector 10. The luer tip 22 of the connector 10 can protrude intothe housing 266 of the needle sheath.

In FIG. 17, the engagement shown in FIG. 16 is illustrated in across-sectional view. The connector 10 is engaged by a syringe 250 and aneedle with a sheath 270. The syringe 250 is threadedly engaged with thethreaded surface 150 of the valve member 16 of the connector 10. Theneedle with sheath 270 is threadedly engaged with the inner threads 26of the shroud 24.

The luer tip 256 of the syringe 250 protrudes into the tube 40 of thevalve member 16. The reservoir 260 of the syringe 250 is in fluidcommunication with the tube 40 of the valve member 16 through the luertip 256.

The connector 10 is engaged with the needle with a sheath 270. Thehousing 266 of the needle with sheath 270 has raised tabs 264 near itsproximal end. The raised tabs 264 threadedly engage the inner threads 26of the shroud 24 of the connector 10. As the luer tip 22 advances intothe housing 266 of the needle 268, the proximal end of the housing 266can contact the struts 42 of the valve member 16. When the needle withsheath 270 is fully engaged with the connector 10, the valve member 16has been displaced a distance which separates the flange section 58 fromthe tapered interior wall of the lumen 28 sufficiently to permit fluidto flow out the windows 54 of the valve portion 16. The fluid can thenflow out the hole 30 in the end of the luer tip 22 and into the housing266 of the needle with sheath 270. The hollow needle 268 permits thefluid to flow from within the housing 266 out the distal tip of theneedle 268. The sealing portion 20 preferably maintains a fluid barrierbetween the outer surface of the tube 40 and the inner surface of thelumen 28, confining the fluid in the lumen and the direction of flowtoward the hole 30 in the luer tip 22. Thus, at this stage, the syringe250 is in fluid communication with the distal tip of the needle 268. Aswas previously illustrated in FIGS. 13 and 14, in some embodiments, theconnector 10 will generally not permit fluid to flow out of the syringe250 without a component engaged with the second end 14 of the connector10. The component illustrated in FIGS. 15-17 is a needle with a sheath270; however, other components, such as those which permit fluid flowand possess a female luer engagement portion, can also be used.

FIG. 18A displays a perspective view of another embodiment of acloseable male luer. The rotatable connector 300 is comprised of ahousing 310, an internal passageway 322 and a seal element 330. Thehousing is further comprised of a luer tip 312, a luer receiver 316 atthe first end of the connector 300, an engagement portion 318, amanipulation portion 320, and a raised portion 340. The seal element 330can have an opening 350 along its face 314 in a transverse direction.The internal passageway 322 can extend from the luer receiver 316 to theluer tip 312. The housing 310 can be composed of a water-impermeablematerial, such as a polycarbonate plastic. The housing 310 can also becomposed of a hydrophobic plastic. Other examples of materials suitablefor construction of the housing 310 are glassed-filled GE Valox 420 orpolypropylene. Depending on the application, many other materials canalso be used.

The housing 310 illustrated is configured to receive a male luer tip atthe luer receiver 316 by threadedly engaging the male luer at itsengagement portion 318. The receiver 316 can conform to ANSI standardsfor a luer receiver. The illustrated manipulation portion 320 has twotabs extending radially from the central axis of the housing 310. Themanipulation portion 320 is configured to aid the user in grasping androtating the connector 300.

The housing 310 illustrated is also constructed to provide a closeablemale luer at its second end. The luer tip 312 at the second end can beconstructed to ANSI standards for a male luer tip. The luer tip joinsthe main body of the housing 310 at the raised portion 340. The raisedportion 340 is constructed to inhibit the luer tip 312 from advancingtoo far into a luer receiver. The housing 310 can also have a recessedportion 342 behind the raised portion 340. The luer tip 312 can alsohave a seal element 330 which has a face 314 towards the second end ofthe connector. The seal element 330 can be any water-impermeable,resilient material, including without limitation, silicone. Theselection of the material for construction of the seal can beaccomplished by one skilled in the art. The luer tip 312 can tapersmaller in a direction from the raised portion 340 as it approaches itssecond end.

The seal element 330 can also have an opening 350 in the face 314 towardthe second end of the connector prior to engagement with any othercomponent. The opening 350 can be a slit in a transverse direction tothe longitudinal axis of the housing 310. The opening 350 can becentered across the face 314, or located in another position on the face314. The seal element 330 can cover the entire second end of the luertip 312, or only a portion thereof. The seal element 330 can be attachedto the housing by an overmolding process, among other attachmentmethods. In such an overmolding process, the housing 310 can be formedby injection molding in a first step, and then in a second step, thehousing 310 can be re-inserted into a mold (or remain in a mold) and anappropriately sized molding pin (not shown) can be inserted through awider end of the housing 310, such as the second end. Silicone materialcan then be injected into the mold to form the seal element 330. Inother embodiments, the seal element 330 can be glued or otherwiseadhered into the housing 310.

As can be seen from the illustrated embodiment in FIG. 18A, the sealelement 330 can inhibit fluid from flowing through the housing 310 whenthe luer tip 312 is not engaged with another component. Thus, when afluid-containing component (not shown) with a male luer connector isconnected to the luer receiver 316, the connector 300 can be used tocontrol flow of fluid through its luer tip 312. For example, when afluid-containing component such as a syringe is engaged with theconnector 300, fluid is permitted to fill the housing 310 of theconnector 300 by flowing through the internal passageway 322, but theseal element 330 can substantially inhibit flow of fluid out the luertip 312. If the interior space of the housing is filled with air oranother gas before the fluid enters, the connector 300 may need to beopened to allow the air or other gas to escape before the fluid canenter. In some embodiments, as described in detail below, the internalsurface of the seal element 330 can be adapted to increase theresistance against the widening of the opening 350, which could allowfluid to escape when the fluid (not shown) exerts a pressure against theseal element 330 from the internal passageway 322. Thus, the connector300 inhibits flow of fluid from a fluid-bearing component when theconnector 300 is attached to the male luer of the fluid-bearingcomponent without another component connected to the luer tip 312 of theconnector 300.

In some modes of use, the opening 350 on the face 314 of the sealelement 330, normally closed in the position shown, can be opened whenthe luer tip 312 comes in contact with a suitable female connector, suchas a Clave® connector sold by ICU Medical, San Clemente, Calif. Anillustrated engagement of this configuration is discussed in detailbelow. The engagement can be achieved in many other ways, and with manyother structures, including connectors other than the Clave connector.

FIG. 18B is a cross-sectional view of the connector 300 illustrated inFIG. 18A. The connector 300 can have an internal passageway 322 whichconnects the luer receiver 316 to the luer tip 312. The engagementportion 318 can be configured to receive an internally threaded shroudof a male luer connector (see FIG. 19). The manipulating portion 320 canextend radially away from the internal passageway 322, as shown. Theseal element 330 can extend along at least part of the internalpassageway 322, and can be disposed across at least part of the secondend of the connector 300. The seal element 330 can extend beyond the endof the luer tip 312. The seal element 330 can have a cross-sectionalarea approximately equal to the housing 310 at the end of the luer tip312. In those embodiments where the luer tip 312 and seal element 330are generally circular, the outside diameter of the seal element 330 canbe equal to the outside diameter of the luer tip 312. The seal element330 is not confined to a circular shape (nor are any other structuresdisclosed herein), and other shapes can be used. In other embodiments,the seal element 330 does not extend beyond the end of the housing 310towards the second end of the connector 300, but can have a maximumouter dimension equal to that of the inner dimension of the luer tip312. The seal element 330 can have a closing portion 324. The closingportion 324 can permit fluid flow through the seal element 330 of theconnector 300, but is biased to generally close the opening 350 in theseal element 330. The structure of the closing portion 324 can beadapted to resist permitting fluid (not shown) from exiting the opening350 when the luer tip 312 is not engaged with another component, asdescribed in further detail below.

As can be seen in FIG. 18C, which is a detail of the cross-sectionalview presented in FIG. 18B, the seal element 330 can comprise the entireface of the second end of the connector 300. In other embodiments, theseal element 330 may not extend beyond the housing 300. The internalpassageway 322 can extend to the seal at the second end of the connector300.

FIG. 19 illustrates a perspective view of the connector 300 adjacent asyringe 360. As in previous descriptions, the syringe can comprise amale luer connector 362, a fluid reservoir 370, a plunger 374, andfinger anchors 372. The luer receiver 316 of the connector 300, whichcan be of appropriate size and shape to engage with standard luerconnectors, is positioned to receive the luer tip 364 of the syringe360. The internal threads 368 of the shroud 364 of the syringe 360 areproperly aligned to threadedly connect with the engagement portion 318.In this way, the receiver 316 can engage the luer connector 362 andconnect the connector 300 to the syringe 360. Before engagement of thesyringe 360 with the connector 300, the fluid within the reservoir 370is not inhibited from exiting the luer tip 364 by any physicalcomponent.

Referring now to FIG. 20, a perspective view of the connector 300threadedly connected to a syringe 360 is shown. The connector 300 can beconnected to the syringe 360, or other medical implement, by many othermeans, such as glue, adhesive, solvent, ultrasonic welding, epoxy,interference fits, mechanical connections, and/or unitary constructions.The receiver 316 (not shown) contains at least part of the luer tip 364of the syringe 360. The luer tip 364 extends at least partially into theinternal passageway 322. The threaded engagement portion 318 is engagedwith the internal threads 368 of the shroud 364 of the syringe 360.Fluid from the reservoir 370 can then flow freely within the housing 310of the connector 300, by way of the internal passageway 322. If theinterior space of the housing is filled with air or another gas beforethe fluid enters, the connector 300 can be opened to allow the air orother gas to escape before the fluid can enter. In some cases, thehousing 310 of the connector 300 may be filled with a gas, such as air.Before the fluid enters the housing 310, the connector may need to beopened to allow the gas to escape before the fluid can flow. The sealelement 330 inhibits fluid from leaving the connector 300. The luer tip312 of the connector 300 can be used to connect the connector-syringe300, 360 combination to other components for controlled fluid transfer.The connector 300 can also be formed integrally with the syringe 360(not shown), such that the housing 310 of the connector is formed by thefluid-delivery end of the syringe. During use of this combinationconnector-syringe, the male luer tip 312 of the connector 300 can, ineffect, replace the luer tip 364 of the syringe for connection purposes.

Certain medications, such as chemotherapy medications, are contacttoxins, and avoiding exposure to the skin is desirable. Such medicationsare often stored in a syringe with a hypodermic needle, such as depictedin FIGS. 15 and 16. Under certain conditions, without the use of acloseable male luer connector, it can be possible for the toxic fluid toflow out of the syringe. Even if steps are taken to avoid accidentalfluid flow, such as orienting the syringe with attached needle such thatgravity aids the retention of the medication within the syringe, themedication can also vaporize and seep out of the hypodermic needle in agaseous state. The use of a closeable male luer between the syringe andhypodermic needle inhibits the uncontrolled flow of medication, in bothliquid and gaseous states. Accordingly, risk of accidental exposure tosuch toxic medications is minimized.

Referring now to FIG. 21, the closeable male luer connector 300 isillustrated in another embodiment, wherein an internally threaded shroud380 is disposed on the housing 310. The shroud 380 at least partially orentirely encircles the housing 310 at approximately the recessed portion342 (visible in FIG. 18A). In some embodiments, the shroud 380 is notattached to the connector 300, and instead can rotate freely about thelongitudinal axis of the connector 300. The raised portion 340 (visiblein FIG. 18A) can inhibit the movement of the shroud 380 towards the luertip 312 of the connector 300. Additionally, the manipulation portion 320of the connector 300 can inhibit the movement of the shroud 380 towardsthe luer receiver 316. The shroud 380 can be threaded consistent withANSI specifications for luer connectors. The shroud 380 can assist theluer tip 312 in forming a connection between the connector 300 and othercomponents (not shown).

With reference now to FIG. 22A, the cross-section of a closeable maleluer connector 400 with a continuously tapering internal passageway 402is illustrated. The housing's 404 tapering internal passageway 402permits for varied injection molding techniques of manufacture. Forexample, if the taper is wider at an end with a luer receiver 406, amolding pin can be tapered in a corresponding manner to closely fitagainst the wall of the internal passageway 402, producing a seal 408that is shorter than the seal illustrated in FIG. 18B.

With reference to FIG. 22B, the seal 408 in the illustrated embodimenthas a closing portion 412 similar to that of the closing portion 324 inFIG. 18B. In addition, the internal surface of the seal 408 can beadapted to increase resistance against permitting fluid from exiting theopening 410 when a fluid (not shown) in the internal passageway 402exerts a pressure against the seal 408. The internal surface of theclosing portion 412 can include slanted surfaces against which suchfluid presses to urge the opening 410 more tightly closed.

Turning to FIG. 23A, a side view of another embodiment of the connector400 of FIG. 22A is displayed. An internally threaded shroud 420 isdisposed about the outer surface of the housing 404.

As can be seen in FIG. 23B, the housing 404 can have a raised portion424 which inhibits axial movement of the shroud 420 toward the luer tip416. The housing 404 can also have a manipulation portion 418 whichextends radially outwardly from the longitudinal axis of the connector400. The housing 404 also has an internal passageway 428 extending fromthe luer receiver 414 to the seal element 430. The manipulation portion418 can inhibit movement of the shroud towards the luer receiver 414 ofthe connector 400. The manipulation portion can also be a convenientplace for the user to place his or her fingers while turning theconnector 400. Additionally, there can be a recessed portion 426 of theconnector 400. The recessed portion 426 can be a portion of theconnector 400 with a smaller outer diameter than the outer diameter ofthe raised portion 424 or the manipulation portion 418. The shroud 420can be disposed on the connector 400 such that a narrow portion of theshroud 420 encircles the connector 400 about the recessed portion 426.The shroud 420 can be unaffixed to the housing 404 and thus free torotate. The internal threads 422 of the shroud can conform to ANSIstandards for luer connectors, allowing the shroud to assist the luertip 416 in engaging the female connector of another component (notshown).

FIG. 23C depicts the closeable male luer connector 400 of FIG. 23B inthe proximity to a suitable female connector 450, such as a Clave®connector sold by ICU Medical, San Clemente, Calif. The female connector450 is similar to that illustrated in FIG. 10.

FIG. 23D illustrates an engagement between the male luer connector 400and female connector 450. The internal threads of the shroud 420 canengage with a threaded region 451 of the female connector 450. The luertip 416 of the male luer connector 400 can advance into the femaleconnector 450 by compressing a compressible seal 454. As the maleconnector 400 advances, a stationary fluid conduit 456 of the femaleconnector 450 can penetrate the opening 448 in the seal element 430 ofmale connector 400. The fluid conduit 456 can advance far enough intothe male connector 400 that the holes 455 advance into the internalpassageway 428 of the male connector 400. Once the holes 455 of thefemale connector 450 are disposed within the internal passageway 428 ofthe male connector, fluid can flow from the luer receiver 414 of themale connector 400 through the internal passageway 428 of the maleconnector 400 to the holes 455 of the fluid conduit 456 of the femaleconnector 450. The fluid can then flow through the holes 455 and into afluid conduit 458 of the female connector 450. Thus, fluid can flow fromthe first end of the male connector 400 to the distal end of the femaleconnector 450 when the two are engaged. When the connectors 400, 450 aredisengaged, the fluid conduit 456 withdraws from the internal passageway428 and the seal element 430 closes, thereby inhibiting fluid flowthrough the male connector 400. Additionally, the compressible seal 411of the female connector 450 returns to its original position, andinhibits flow through the holes 455 in the fluid conduit 456.

With reference now to FIG. 24A, a closeable male luer connector 500 isdisplayed in a perspective view. The connector 500 has a housing 510 anda seal 514. The housing is comprised of a manipulation portion 512. Inthis exemplary illustration, the manipulation portion 512 includes wings516. The wings 516 are adapted to provide a place for the user to graspand rotate the housing 510 of the connector 500.

Referring now to FIG. 24B, the connector 500 of FIG. 23A is shown incross-section. The wings 516 are shown as extending outward from thelongitudinal axis of the connector 500 and towards the luer receiver 518of the connector. The internal passageway 520 of the housing 510 has acontinual taper, as described in the embodiment of the connector 400 inFIG. 22A.

Turning to FIG. 25A, a side view of a closeable male luer connector 600is illustrated. The connector 600 has a housing 610, a seal element 614,and a shroud 620. The housing comprises an internal passageway 640, aluer tip 612, and a manipulation portion 616. The manipulation portioncan be constructed to comprise two wings 630, as described in FIG. 24A.The shroud can have internal threading 622, and such threading can beconstructed to comply with ANSI specifications for luer connectors. Theseal element 614 can be biased closed when not engaged.

With reference now to FIG. 25B, a cross-sectional view of the connector600 from FIG. 25A is displayed. The shroud 620 can encircle the housing610 at a recessed portion 652 of the housing 610. A raised portion 650can inhibit motion of the shroud 620 in the direction of the second endof the connector 600 while the manipulation portion 616 can inhibitmotion of the shroud in the direction of the first end of the connector600. The internal threading 622 of the shroud 620 can be used to engageother components (not shown) when used in conjunction with the luer tip612. The continuously tapering internal passageway 640 hascharacteristics that assist in injection molding as discussed withregard to FIG. 22A.

Referring to FIG. 26A, a perspective view of a closeable male luerassembly 725 comprising a closeable male luer 700 and a flexiblyconnected female luer connector 750 is displayed. The closeable maleluer 700 can embody any number of the aspects and features described inthis application. The female luer connector 750 is adapted to receive astandard male luer connector (not shown). The female luer connector 750is located adjacent the male luer connector 700 and flexibly connectedto it. The female luer connector 750 comprises an internal passageway752, a luer receiver 754, and an engagement portion 756. The internalpassageway 752 places the luer receiver 754 in fluid communication withan internal passageway of the closeable male luer connector 700. Thecloseable male luer connector 700 can be attached to the female luerconnector 750 through a flexible segment 760. In some embodiments, sucha segment 760 can include an accordion-like flexible portion ofresilient material. In other embodiments, a straight, flexible materialcan be used. In other embodiments, both a flexible outer segment and aflexible tube can be used to connect the closeable male luer 700 withthe female luer 750.

With continued reference to FIG. 26A, the flexible segment 752 permitsthe user to orient the female connector 750 of the assembly 725 in adifferent attitude than that of the closeable male luer connector 700.As an example, the closeable male luer 700 can remain stationary againsta patient's arm while the female connector 750 is angled away from thearm to assist in easy connection with a syringe or other component (notshown). By flexibly connecting the closeable male luer 700 to the femaleluer connector 750, the moment generated by moving the female luerconnector 750 is accepted at a point between the two components of theassembly 725 and is less likely to be transmitted to another component(not shown) attached to the closeable male luer connector 700. Such acomponent could include an I.V. site, where angling of the connectioncould result in harm to the patient. Moreover, the moment will be lesslikely to bend and/or dislodge the tip of the tube 40 from the interiorof the lumen 28 (see, e.g., FIG. 28).

FIG. 26B illustrates another embodiment of a closeable male luerassembly 800 comprising a closeable male luer connector 825 and aflexibly connected female luer connector 850. The connectors 825, 850and their components are similar in many respects to the embodimentdepicted in FIG. 26 and can embody any number of the aspects andfeatures described above. The closeable male luer connector 825 and thefemale luer connector 850 are flexibly connected by a connecting member860. The connecting member 860 places the connectors 825, 850 in fluidcommunication. The connecting member 860 illustrated here comprises anaccordion-shaped plastic conduit. The connecting member 860 isconfigured to permit the closeable male connector 825 and the femaleluer connector 850 to be positioned at different angular orientations.By way of example, the closeable male luer connector 825 can remainstationary while the female luer connector 850 can be positioned at anangle to the closeable male luer connector 825. In another example, thefemale luer connector 850 can remain stationary while the closeable maleluer connector can be positioned at an angle to the female luerconnector 850. In yet another example, the closeable male luer connector825 and the female luer connector 850 can both be placed at an angle.

As described above, some medications, including those used duringchemotherapy, can be harmful through certain forms of exposure to apatient. For example, exposure to the skin can sometimes result in achemical burn. Inhalation of aerosolized forms of some medications canbe harmful. Thus, control over the containment of the medication ishighly desirable.

At present, some potentially harmful medications are distributed insealed vials. The medication is removed from the vial by inserting aneedle, and drawing the medication into a syringe. The needle is thenwithdrawn from the vial and the medication can be dispensed. However, byinserting the needle into the medication for drawing into the syringe,medication is disposed on the outside of the needle, which caninadvertently come in contact with the skin and cause harm.Alternatively, an injector which penetrates the vial with a withdrawalmechanism can be used. In such an injector, the medication is drawnthrough the mechanism and passed directly to a needle for injectionwithout the additional step of withdrawing the mechanism from the vial.Even if such an injector is used, there is still the possibility oflatent medication remaining on the needle used to inject the medication,or on the mechanism after the vial is decoupled.

Additionally, some medications can be distributed by attaching a needleto a syringe with the medication located therein. The engaged syringewith medication and needle is sterilized and placed into avacuum-sealable container. The container is then evacuated and sealed.This type of arrangement can result in the draw of medication outthrough the syringe when the container is evacuated. While in the sealedcontainer, the medication may aerosolize or coat the outer surface ofthe components.

Additionally, when the ambient atmospheric pressure of the treatmentlocation is different, particularly lesser, than that of the internalpressure of the medication within a container, there is the possibilitythat an uncontrolled spray of the medication occurs when fluidcommunication between the medication and the ambient atmosphere occurs.For example, medication may escape when a vial with a greater internalpressure than the ambient atmosphere is penetrated by a needle fordrawing the medication into a syringe. Alternatively, medication mayescape when the needle is withdrawn from the vial before the vial sealcompletely closes.

With a closeable male luer, flow of the medication out of a syringe witha needle is inhibited, except during desired application. For example,in some embodiments, a syringe with a closeable male luer connected willnot leak medication when packaged for shipment, even if the package isvacuum-sealed. Once the package is opened, the male luer connector canbe engaged with a female luer connector of an IV tube, for example, andthe medication dispensed only when the connection is engaged. Followingflow of the medication from the syringe through the engaged connectorsand into the IV tube, the male luer connector can be disengaged from thefemale luer connector. As described above, the male luer connector canclose on disengagement, preventing excess flow through the connector.When a closeable female luer connector, such as a Clave® connector soldby ICU Medical, San Clemente, Calif., is used, flow is inhibited fromexiting the female connector as well.

Additionally, a syringe with a closeable male luer can be engaged with aneedle as described above. Flow through the needle can thus becontrolled by proper use of the closeable male luer connector.

Medication can also be disposed within a syringe with an integrallyformed, and/or permanently attached, closeable male luer.

Thus, direct exposure of the dangerous medications described can beessentially limited to the highly controlled environments where themedications are produced and contained. Such medications can be placedin a syringe with a closeable male luer connector prior to distributionfor use, minimizing the risk of inadvertent exposure of the medicationduring use of the medication.

Any features of the embodiments shown and/or described in the figuresthat have not been expressly described in this text, such as distances,proportions of components, etc. are also intended to form part of thisdisclosure. Additionally, although this invention has been disclosed inthe context of various embodiments, features, aspects, and examples, itwill be understood by those skilled in the art that the presentinvention extends beyond the specifically disclosed embodiments to otheralternative embodiments and/or uses of the invention and obviousmodifications and equivalents thereof. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combined with, or substituted for, one another inorder to perform varying modes of the disclosed inventions. Thus, it isintended that the scope of the present invention herein disclosed shouldnot be limited by the particular disclosed embodiments described above,but should be determined only by a proper reading of the claims.

1. A luer connector comprising: a housing with a hollow bore having afirst end and a second end wherein the second end comprises a male luerwith an interior inward ledge at the tip, the inward ledge extendingtowards the central axis of the hollow bore; a rigid valve memberconfigured to at least partially extend through the housing, the valvemember having a first opened end and a second closed end, wherein thesecond closed end tapers and is adapted to seal the hollow bore of thehousing at the second end of the housing by contacting the inward ledgeand comprising: a passageway within the valve member; at least oneopening near the closed end of the valve member extending outwardly fromthe passageway through the valve member; at least one strut attached tothe valve member, at least a portion of the strut extendingsubstantially parallel to the central axis of the valve member; aretaining member configured to couple the valve member and the housing;and a sealing element disposed within the housing and configured toinhibit fluid communication through the hollow bore of the housingbetween the interior of the male luer tip of the housing and the firstend of the housing.